The Australian regulatory and reimbursement agency have particular requirements in their assessments of applications for Medical Devices intended for supply in Australia. A well-defined approach or a clearly set up manual is nonexistent but the expectations are clear, if the application has errors or a document is not conclusive than the assessment of the associated application is delayed or worse still, the complete submission may just be rejected. You may then need to start again and potentially lose your fees.
In this two-day workshop conference, you will learn the complete pathway. You will be shown what and when to submit information, particular requirements, expectations from the agencies and the determination of a forecast launch date for your products. Through case study analysis, we will examine best practices to minimize errors in order to achieve product approvals.
Learning Objectives:
Upon completing this course participants should:
- Understand keys areas of the legislative instrument dictating regulatory requirements
- Easily navigate pertinent website for specific documents for the application to the authorities
- Explore the Regulatory and Reimbursement landscape, for presentation of the competitive and product comparator market to your sales and marketing team
- Understand your accountability as an Applicant, Sponsor and Manufacturer for products supplied in Australia
- Understand the complete submission application pathway for products with all risk classifications
- Assess and critique documentation intended to be submitted
Who will Benefit:
This course is designed for people tasked with submitting applications to the Regulatory or the Reimbursement Government Authority for Medical Devices (Exclusion are IVD products).
Personnel in the following areas will benefit from the course:
- Personnel involved in start-up or in well-established global companies with intentions to market their products in Australia
- Regulatory professionals
- Compliance professionals
- Personnel involved in Research and Development
- Marketing professionals
- Document control specialists
- 08.30 AM - 09.00 AM: Registration
- 09.00 AM: Session Start
- Day 1 -Lectures and Workshop Exercises
- Module 1: Medical Devices 101 – An introduction
- The Regulatory and the Health Economist – The Strategist or an Administrator
- How do I confirm that my product is regulated as a Medical Device – What if decision tree
- The assessment of the Regulatory landscape_ Who’s who in Australia -Search options
- Responsibilities as the applicant and accountability of the sponsor and manufacturer
- Elements of a contractual agreement between all parties -
- Available alternative options of supply
- Module 2: Legislative imperatives in the submission process
- Therapeutic Goods Act
- Significance of particular clauses
- Therapeutic Goods Regulations
- Significance of particular clauses
- Therapeutic Goods Act
- Module 3
- The intended purpose of your product and claims
- The Australian Essential Principles Checklist
- Comparatives to the EU Essential Requirements Checklist
- The Australian Classification Rule
- Comparatives to the EU Classification Rule
- Module 4: Quality Management System 101- ISO 13485
- Let’s talk about document management and control
- Excel 101, power of use and the beauty of hyperlinks
- Risk assessment 101 - ISO14971
- When does risk assessment stop
- Clinical product Assessment
- Differences between Meddev 2.7/1 rev 4 and Australian proposed clinical evidence guideline
- Comparatives of Australian guidelines to MEDDEV 2.7/1 revision 4
- Labels and requirements
- Let’s talk about document management and control
Let’s talk about Brexit and Regulatory implication with Europe and Australia
The Technical file and compilation
Key elements for inclusion – Marriage of MED/2.5.1/Rec5, GHTF STED, IMDRF/RPS WG/N9, TGA’s supporting Data form
- Day 2 -Lectures and Workshop Exercises
- Module 5: TGA application Process
- Application type and Conformity Assessment approach
- The Australian Declaration of Conformity and significance and relationship with a well set up contractual agreement.
- The GMDN code, its significance and cost implications
- Fees, timelines and assessment turnaround time to approval
- Particular requirements from your manufacturer in the submission process
- Module 6: The Australian Healthcare System and Government reimbursement of implantable products
- Does your product qualify for reimbursement
- The Prosthesis List Management System
- Imperatives in the application process
- Fees, timelines and assessment turnaround time to approval
- Module 7: Post market accountabilities
- Adverse Reactions – Global vs locals reporting
- Recalls and related responsibilities
- IRIS
- Post market complaints reporting and the essentials of a common Standard Operating Procedure for Reporting
- Module 8
- Workshop and case study
- Review of inputs into the technical file
- Documentation management system in place
George Azoury
Chief Executive Officer,RQSolutions Pty Ltd
George Azoury is principal and founder of RQSolutions. A leading consulting company located in Sydney, Australia, servicing the Medical Device Industry since 2002. Previous to this, George has held various local and regional positions in Regulatory, Compliance and Health Economics in a number of national and multinational companies. George is well known at both a local and global level with involvements with a number of companies ranging from the start-ups to the well-established manufacturing facilities in Europe, US and the Asia Pacific region.
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